Pediatric Cardiac Output Monitoring Observational Study

NCT04465370 | Completed Results FDA Device

• 1 other identifier: 2019-08
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 3

Brief Summary

To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight system to intermittent thermodilution Swan-Ganz, in order to expand the indications of FloTrac, ClearSight and Swan-Ganz thermodilution pulmonary artery catheter to the pediatric population 12 to 18 years of age.

Conditions

Pediatric ALL

Keywords

Hemodynamic Monitoring; Cardiac Output

Outcome Measures

Primary Outcomes (4)

• Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output

  Bias of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis

  Duration of cardiac catheterization procedure, an average of 2 hours

• Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output

  Precision of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis

  Duration of cardiac catheterization procedure, an average of 2 hours

• Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output

  Bias of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis

  Duration of cardiac catheterization procedure, an average of 2 hours

• Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output

  Precision of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis

  Duration of cardiac catheterization procedure, an average of 2 hours

Interventions

Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight DEVICE

A Swan-Ganz catheter, FloTrac transducer, ClearSight finger cuff and ForeSight Elite sensors will be placed prior to the start of the catheterization procedure. Intermittent cardiac output and other hemodynamic parameters will be collected throughout the duration of the procedure and analyzed according to the Statistical Analysis Plan.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Males and Females, 12 to 18 years of age at the time of screening. Who presenting to Cardiac Catheterization Lab for right heart catheterizations.

You may qualify if:

• Subjects who are 12 to 18 years of age
• Subjects who have signed the Informed Consent Form
• Subjects who are projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output measures
• For those Subjects who have had a cardiac transplant,Subjects who are at least 2 weeks post cardiac transplantation
• Subjects with planned pressure monitoring with an arterial line

You may not qualify if:

• Subjects with contraindications for Pulmonary Artery Catheters Placement and monitoring (recurrent sepsis, or with hypercoagulopathy);
• Subjects with contraindications for Arterial Line Placement;
• Subjects with an extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand (i.e., Raynaud's Disease).
• Subjects with a physical site area too limited for proper Sensor placement
• Subjects with finger size less than the smallest finger cuff size
• Documented ≥ moderate pulmonary hypertension (PAPm \> 25mmHg, PVRI \> 3.0 WUxm2)
• Presence of intracardiac shunting (i.e., ASD, VSD)
• Aorto-pulmonary collaterals
• ≥ Moderate tricuspid regurgitation, per echocardiogram criteria
• \> Moderate Aortic or pulmonary regurgitation, per echocardiogram criteria
• Persistent cardiac arrythmias during the cardiac catheterization period (\> 3min)
• Vascular abnormalities of the arterial system (i.e., connective tissue disorders, mid-aortic syndrome)

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (3)

UF Health Shands Children's Hospital

Gainesville, Florida, 32610, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Cristina Johnson
• Organization: Edwards Lifesciences

CC_Clinical_Affairs@edwards.com

888.713.1564

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: September 2, 2020
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: November 18, 2024
• Results First Posted: November 18, 2024

Record last verified: 2024-09

Locations

US (3)